SAN DIEGO, June 4, 2018 /PRNewswire/ -- OncoSec Medical
Incorporated (OncoSec) (NASDAQ:ONCS), a company developing
intratumoral cancer immunotherapies, today announced the
presentation of a Trials in Progress poster at the American Society
of Clinical Oncology (ASCO) 2018 Annual Meeting taking place in
Chicago, IL.
Titled, Trial in Progress, A Phase 2 Study of Intratumoral
pIL-12 Plus Electroporation In Combination With Intravenous
Pembrolizumab In Patients With Stage III/IV Melanoma Progressing on
Either Pembrolizumab or Nivolumab Treatments
(PISCES/KEYNOTE-695), the poster provides an update on
OncoSec's global, multi-center, registration-directed open-label
Phase 2b clinical trial, assessing
the Company's investigational therapy, (intratumoral pIL-12
[tavokinogene telseplasmid] delivered with electroporation) ("tavo"
or "ImmunoPulse® IL-12"), and the approved anti-PD-1 therapy
pembrolizumab, in patients with unresectable metastatic melanoma
who have progressed or are progressing on an anti-PD-1 therapy.
PISCES/KEYNOTE-695, a phase 2b,
Simon 2-stage multicenter study of tavo in combination with
intravenous KEYTRUDA, will enroll approximately 48 patients with
histological diagnosis of melanoma with progressive locally
advanced or metastatic disease defined as Stage III or Stage
IV. Stage 1 of the study will enroll 23 patients. The
primary endpoint will be the Best Overall Response Rate (BORR).
Numerous sites in the U.S., Australia, and Canada are open and enrolling patients. The
Company anticipates that enrollment in stage 1 will be completed by
the third quarter 2018.
"Despite the addition of immunotherapy and targeted therapies,
disease progression continues to occur in a significant percentage
of advanced melanoma patients," said OncoSec Chief Clinical and
Regulatory Officer, Sharron
Gargosky, Ph.D. "We are pleased with our progress as we
continue to enroll patients in the KEYNOTE-695 trial, which is
evaluating the tolerability and efficacy of pembrolizumab plus tavo
in Stage III/IV melanoma patients who have progressed or are
progressing on approved checkpoint inhibitors."
The Company's prior Phase 2 combination study of tavo and
pembrolizumab (OMS-102) in 22 patients unlikely to respond to
anti-PD-1 therapy demonstrated a 50% best overall response rate and
a 41% complete response rate. In addition, the trial showed a 57%
progression free survival (PFS) rate at 15 months (median PFS not
yet reached) and 100% (11/11) duration of response. In clinical
studies to date, tavo has demonstrated a favorable safety profile
and has been well tolerated.
PISCES/KEYNOTE-695 is the second combination study conducted
with tavo and pembrolizumab and, if successful,
could form the basis for a BLA under the accelerated approval
pathway.
Tavo has received both Orphan Drug and Fast-Track Designation by
the U.S. Food & Drug Administration.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc.
ImmunoPulse® is a registered trademark of OncoSec Medical
Incorporated.
To learn more about the trial,
visit www.oncosec.com. Additional details can also be
found at www.clinicaltrials.gov via NCT03132675.
About PISCES/KEYNOTE-695 (Anti-PD-1 IL-12 Stage
III/IV Combination Electroporation Study)
PISCES/KEYNOTE-695
is a global, multicenter phase 2b, open-label trial of intratumoral plasma
encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by
electroporation in combination with intravenous pembrolizumab in
patients with stage III/IV melanoma who have progressed or are
progressing on either pembrolizumab or nivolumab treatment. The
Simon 2-stage study of intratumoral tavo plus electroporation in
combination with pembrolizumab will enroll approximately 48
patients with histological diagnosis of melanoma with progressive
locally advanced or metastatic disease defined as Stage III or
Stage IV. The primary endpoint will be the Best Overall Response
Rate (BORR).
About Metastatic Melanoma1
Melanoma is a
type of skin cancer that begins in skin cells called melanocytes.
As the cancer progresses, melanoma becomes more difficult to treat
once it spreads beyond the skin, such as the lymphatic system
(metastatic disease). Given its occurrence young individuals, the
potential years of life lost to melanoma can be higher when
compared with other cancers. Although melanoma is a rare form of
skin cancer, it accounts for over 75% of skin cancer deaths. The
American Cancer Society estimates that approximately 87,000 new
melanoma cases and 10,000 deaths from the disease will occur in
the United States in 2017.
Additionally, the World Health Organization estimates that
approximately 132,000 new cases of melanoma are diagnosed around
the world every year.
1 American Cancer Society
(https://www.cancer.org/cancer/melanoma-skin-cancer/about/key-statistics.html);
World Health Organization
(http://www.who.int/uv/faq/skincancer/en/index1.html)
About OncoSec Medical Incorporated
OncoSec is a
biotechnology company developing DNA-based intratumoral
immunotherapies with an investigational technology,
ImmunoPulse®, for the treatment of cancer. ImmunoPulse
is designed to enhance the local delivery and uptake of DNA-based
immune-targeting agents, such as plasmid encoded IL-12
(tavokinogene telseplasmid or "tavo"). In Phase 1 and 2 clinical
trials, ImmunoPulse® IL-12 has demonstrated a favorable
safety profile, evidence of anti-tumor activity in the treatment of
various solid tumors, and the potential to reach beyond the site of
local treatment to initiate a systemic immune response. OncoSec's
lead program, ImmunoPulse IL-12, is currently in clinical
development for metastatic melanoma and triple-negative breast
cancer. The program's current focus is on the significant unmet
medical need in patients with melanoma who are refractory or have
relapsed on anti-PD-1 therapies. In addition to tavo, the Company
is also identifying and developing new immune-targeting agents for
use with the ImmunoPulse platform. For more information, please
visit www.oncosec.com.
CONTACT
Investor Relations:
Stern Investor Relations
Will O'Connor
Phone: (212) 362-1200
will@sternir.com
Media Relations:
Janine McCargo / David Schemelia
Tiberend Strategic Advisors, Inc.
Phone: 212-827-0020
jmccargo@tiberend.com
dschemelia@tiberend.com
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SOURCE OncoSec Medical Incorporated